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PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics

Study acronym: PIM-BARS
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Secondary endpoints: 4 to 3v9
  3. Secondary endpoints: 2 to 4v8
  4. Primary completion date: Aug 31, 2026 to Aug 31, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v7
  5. Primary completion date: Aug 31, 2024 to Aug 31, 2026
    • Study completion date: Nov 15, 2024 to Dec 31, 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria revised
    • Study description shortened, about 5 words
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study description expanded, about 8 words
    v3
  4. Start date: Jun 1, 2022 to Jul 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to assess the incidence of potentially inappropriate medication (PIM) administration, polypharmacy, and potential drug-drug-interactions (PDDIs) in cardiovascular patients enrolled in the reimbursement program in the time of coronavirus disease (COVID-19) pandemic. Medical information system (MIS) "BARS" will be used for inclusion and retrieval of relevant data of cardiovascular patients enrolled in the reimbursement programs in the Tomsk Region. The incidence rates of PIM prescriptions will be assessed in patients aged 75 years and older. Potentially inappropriate medications will be defined according to 2015 Beers criteria. Polypharmacy will be defined as being administered five or more medications at the same time. PDDIs will be checked with Medscape Drug Interaction Checker and rated as 'Contraindicated', 'Serious', and 'Requiring Monitoring'. Combined analysis of retrospective and prospective occurrences of study parameters will be performed. PIM-BARS will evaluate the incidence rates and patterns of PIM prescriptions, polypharmacy, and PDDIs in elderly cardiovascular patients enrolled in the reimbursement program in the time of COVID-19 pandemic.
Trial Details
NCT Number NCT05336565
Lead Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions
(from sponsor)		 Potentially Inappropriate Medications
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov